Executive Insight AG. Company Snapshot Presentation. Our offering

Personalized Medicine

How ready is the market for you and how ready are you for the market?

2

Estimated Development of Personal Medicine Core Areas

The future clearly lies

in Personalized Medicine

*Esoteric Lab Services or Tests involve testing for substances (e.g. biomarkers) which is usually not performed in a “routine clinical lab”. These Tests usually require

specialized personnel and hardware therefore they are often outsourced from hospitals to research labs (e.g. part of big university clinics, specialized private labs etc.)

Source: PwC 2012

$ bn

Total: $ 24bn

Total: $ 42bn

+61%

The Personalized Medicine

Market Size is said to

experience substantial

growth in the next years -

up to $ 42bn by 2015 (MDx

tests and targeted

therapies) compared to $

24 bn. in 2009

3

In principle,

everyone stands to win

Lower cost Right drugs for the

right patients, especially

for cancer

Clearer basis

for developing

treatment guidelines

Better balance between

efficacy vs cost

Diagnostics:

A more attractive business model

built on value based pricing

Better prediction of

treatment outcome

Higher efficacy &

less side effects

Pharma / Diagnostics

Industry

Policy Makers

Payers/ Assessors

Providers

Prescribers/ Pathologist

Patient

Pharma:

From the outdated blockbuster

model to niche-busters

4

Fearful that biopharmas use personalized

medicine to disguise higher pricing

Poor understanding of the difference

between the prognostic vs predictive tests

Sceptical of unfamiliar clinical data

evidence used to justify economic value,

yet unable to propose alternatives

However, many Policy Makers and Payers/assessors

are unwilling, unsure or unprepared to adapt

5

No holistic view of Rx and CDx

(undermines the whole concept of

personalized medicine)

Rx assessment mechanisms

blindly applied to CDx (eg.: same

data requirements)

Technology-based reimbursement

criteria may not recognize the

value of CDx

The current Market Access system is therefore

unable to unleash the full value of CDx

6

In turn, Biopharmas tread

in uncharted waters in Market Access

With different funding dynamics for CDx and Rx, how

will unfunded CDx jeopardize MA of the Rx?

Will the CDx linked to a Rx go through the

reimbursement process together or separately? How

will it affect the timeline?

What new add-on funding opportunities exist for

combined Rx/CDx approaches?

How should the CDx feed into the health economic

data model?

How can we enhance Market Access by combining the

early access programs of both the Rx and CDx?

7

Biopharmas also face new challenging questions

in developing a successful business model

What is the best “distribution model” for promoting the

CDx component and overcoming any local lab capacity

hurdles?

How can payer partnership program enhance Market

Access of your Rx/CDx combination, if at all?

Which pricing option (combined or separate) for Rx/CDx

in which markets give you a competitive edge?

Executive Insight AG. Company Snapshot Presentation. Our offering

Personalized Medicine

This is where ExecutiveInsight comes in…

9

Executive Insight can undertake a rigorous review

of your Pricing and Reimbursement Strategy

P&R pathway & evidence

requirements

Best Market Access option

Diagnostic Test

G-BA

• Test for early detection§§§ 92; 25; 26 SGB-V

Kap. 2 § 10 VO-GBA

• Real innovation:

Kap 2 § 2 (1) VO-GBA

- Either: not included in the EBM in any way

- Or: signif icant change or underlying technology

Benefit attributed

(+ / -)

Potential for

benefit recognized

Coverage with evidence development

§ 137e

Performs benefit assessment§§ 135; 137c

Decision§§§ 92; 25; 26 SGB-V

Kap. 2 § 10 VO-GBA

G-BA consults BA on significance of innovation

Kap. 2 § 2 (2) VO-GBA

• Technology already(‘somewhat’) included in EBM

through (generic coding, or code

for highly similar procedure)

Performs HTA assessment (if required by the BA)Anlage 22 Kap. 32 EBM

Decides on entry of new code andEBM point value

§ 87, SGB-V

LEGEND:

Actions

Requirements

Requirements test early detection

Legal basis

Institution or Decision

Bewertungs-

ausschuss

AG Labor

Align expectations with external and internal stakeholders

Enable optimal use of resources

Develop win-win value propositions for key stakeholders

Needs of the network of stakeholders

Link Strength 1 2 3 4

Market Access

Medical Experts

Interviews covering all relevant clinician and payers for the in- and outpatient setting

Leverage Executive

Insight expert network

StakeholderPayers KOLs

National Regional Hospital Clinicians Pathologist

Number of

interviews7x 2x 5x 7 2x

10

...set up a winning

sustainable Business Model

Payer partnership Distribution mix Pricing models

Assess feasbility of

testing clusters for

faster patient

access and uptake

Explore schemes which

can increase chance of

targeted prescription (eg: introduction of eligibility

quality assurance)

Propose models that

reflect new customer

needs and value

perception (combined or separate

offerings)

Performance based

agreements (PBS)

Value added agreements

(VAA)

Financial based

agreements (FBA)

11

Develop CUP, NPP

and ROK for faster

patient access and

uptake

... and help you prepare

efficiently for successful launch

Early access programs

Pre-launch activity roadmap

Highlight critical

success factors that

ensure optimal and

timely preparation for

launch

12

Do not use personalized medicine as a disguise

for pure market expansion

Reach out to a truly eligible patients through

quality management programs

Do not circumvent standard Market Access

options to accelerate reimbursement

Help to shape the system so that fast access

becomes possible through standard processes

We pursue the true spirit of releasing

the full value of Personalized Medicine

Acceleration instead

of circumvention

A true personalized

medicine approach

13

We bring to your projects our unique set

of expertise in Personalized Medicine

Medical experts with the in-depth

understanding of patient pathways to

evaluate and propose MA options

AG Labor

KBV / GKV-SVÄrztliche Berufsverb.

Med. Fachgesellsch.Herstellerverbände

Dürfen einen Antrag auf Aufnahme in den EBM stellen

Datenanforderungen (außer Antrag kommt von KBV / GKV-SV) sind wie folgt:

- Beleg des medizinischen Nutzens durch klinische Studiendaten (ggf. vergleichende Studien zu

etablierten Parametern; insbesondere wenn diese ein Substitutions- / Verbesserungspotential aufzeigen

- Angaben zu Kosten und Patientenvolumenentwicklung ‚Budget Impact‘

Rein administratives Institut (Kopf dahinter ist das COC-L)

Bestehend aus 7 KBV und 7

GKV-SV Vertretern

Antrag

COC-L

Beratung / HTA

MDS / MDK Der MDK / MDS hätte die Möglichkeit diese

HTA Kompetenz aufzubauen, hat sich bisher aber noch nicht in diese Richtung positioniert

Das Kompetenzzentrum Labor (COC-L) wird fast ausnahmslos bei jedem Antrag involviert und ist im Endeffekt fast gänzlich

für die Empfehlung des AG Labor verantwortlich

Bewertungs-

ausschuss

Vorbereitung /

Empfehlung

Entscheidung über Aufnahme

Entscheidung über Punktewert (Bazar artige Verhandlung)

Nein Ja

3 M

on

ate

falls

als

Vo

rau

sse

tzu

ng

in d

er F

ach

info

rma

tio

n e

rwä

hn

t, a

nso

nste

n

ka

nn

die

Au

fna

hm

e in

de

n E

BM

lä

ng

er a

ls e

in J

ah

r d

au

ern

Aufnahmeverfahren EBM (= ‚black box: Informationen zu Bewertungsstatus und Entscheidungsbegründungen müssen nicht offen gelegt werden)

P&R country experts with

experienced in P&R pathways

and evidence requirements

or

MDx labOP-Präparat

or

MDx-lab*

OP-Präparat

or

Zeit / Krankheitsentwicklung

I II III IVStage:(Platin Chemotherapie)

(MAGE-A3)

(Xalkori)

(Iressa)

>90% <10%

Ambulant Stationär Histologie-

lab

Biopsie

(Durch die adjuvante Indikation wird die Genmutationsanalyse

an dem OP-Präparat vorgenommen werden)

DRG

EBM

>95%

DRG (+ZE)

EBM

EBM~70% DRG / Drittmittel

(Nur in „late stage“

Fällen initiiert das

KH die Therapie)

(ZE können den Anteil

der stationären

Behandlungen erhöhen)

(Platin Chemotherapie + Avastin)

(Tarceva)

~30%

“You get access to a senior consulting team who have deep competency and experience in their respective areas.”

Global Top 3 Pharma,

Specialty Care Excellence

“…they're working with you and not just putting a lot of junior people in the projects to learn and be trained”

“they came across as more knowledgeable and more experienced”

14

We take a front seat in shaping

Personalized Medicine policies

Member of standing panel of 10 payers and

5 policy makers from major European

markets, competent in all questions related to

Personalized Medicine

Publish articles on early

access programs and payer

partnerships programs

(‘innovative contracting’)

Track Record

Developed pricing models for 5 major Rx/CDx solutions

Accompanied PPP’s from initial discussions between Payers and

Pharma to successful PPP implementation

Established test cluster pilots successfully in major EU markets

Finally, our client-partners seem

to like the way we work with them

Open Collaboration

Creative Pragmatism

• We challenge constructively

• Before going into new solutions, we leverage and maximize our customer internal knowledge, expertise and competences

“they made my priorities their priorities, they really did”

“the collaboration and flexibility is a real strengths of theirs”

“they are very good at being a critical friend“

“they have a pragmatic view of how things actually get

implemented and executed once you develop the strategy “

“merging within the team culture and acting as a part of the team”

• We develop an approach based on our experience with what works and what doesn’t

• We provide actionable recommendations that remain valid after we leave

“they have just delivered very strong results consistently”

“fantastic brains and innovation that they have “ they do generate a chemistry match

between themselves and the customer

Uncovering your true needs

by embedding ourselves in your team

16

Company address:

Your contact persons:

If you want support in defining your plans and

can identify with our thinking, contact us

Andrea Sobrio

Mobile: +41 79 456 87 16

a.sobrio@executiveinsight.ch

Klarissa Hoday

Mobile: +41 79 446 93 79

k.hodayl@executiveinsight.ch

16

Executive Insight AG

Metallstrasse 9

CH-6304 Zug

Tel. +41 (0)41 710 71 63

www.executiveinsight.ch

info@executiveinsight.ch

17

Appendices – About Executive Insight

Our place in the industry –

consistent thought leadership

Regionally based Business Model for Narrow indication

products

Network Based Commercialization

Payer Engagement and Contracting

Beyond the Pill

2000 2004 2007 2011

Networked Healthcare Series

Journal of Medical Marketing

Organisational Polygamy

Pharmaceutical Executive

Move from block busters to niche products

Increasingly complex and intertwined environment

Emerging power of payers

Value expectations along the whole patient

pathway

Our flagship methodologies provided timely answers to the most challenging issues

Check out our website for all related publication and TL on the topics www.executiveinsight.ch/publications

Beyond The Pill: More than Just a Slogan

Farmafocus

Innovative Contracting

Pharmaceutical Executive

Our team - a unique mix of industry,

consulting and medical backgrounds

Interdisciplinary team of 20

professionals

Meet some of our experts here: (see the entire team online)

CONSULTING EXPERTS INDUSTRY EXPERTS MEDICAL EXPERTS

Suzan Esslinger • Theoretical medicine,

PhD in Molecular Biology • Expert for Medical Info.,

Education & Regulatory

Sandra Schoenes • Medical doctor • General and

orthopaedic surgeon

Andrea Sobrio • > 10 years healthcare

consulting experience • Focus: Market Access,

Commercial Models

Meike Wenzel • > 10 years healthcare

consulting experience • Focus: Sales, Customer

& Market Insights

Marc Pesse • > 10 years healthcare

consulting experience • Focus: Network

Mapping & Mgt.

Eric Janvier • > 17 years pharma

industry experience • Finance & Business

Development

Wendy van der Lubbe • > 7 years pharma

industry experience • Product Mgt. &

Medical Affairs

Francesca Boggio • > 3 years medical

device industry • > 8 years consulting • Strategic marketing

Cover the EU big 5 languages (English, German, French, Italian, Spanish) and beyond (e.g. Chinese)

Dr. Morteza Yazdani • PhD in Neuroscience • Diploma in

Biotechnology

Our services

MARKET ACCESS

We support our clients in in-depth understanding of the HC environment and the design of solutions that meet payers objectives and needs

REGULATORY

We support you with building a regulatory strategy to successfully accompany your product through its entire life cycle

MARKETING

We support our clients in developing a compelling value proposition that goes beyond the product to ensure “value beyond the pill”

SALES

We help you find the right balance between adding true value to customer interactions and realising efficiencies

CUSTOMER & MARKET INSIGHTS

We offer innovative methods for generating fresh customer insights

Our clients